Coverage is subject to the specific terms of the member’s benefit plan.
The use of inclisiran (Leqvio) may be considered medically necessary when ALL of the following criteria are met:
- The individual has LDL levels of >70 mg/dL after a 90-day trial of each of the following, as evidenced by paid claims or pharmacy printouts:
- A PCSK9 inhibitor combined with Crestor (rosuvastatin) ≥20 mg or Lipitor (atorvastatin) ≥ 40 mg; and
- Nexlizet combined with Crestor (rosuvastatin) ≥20 mg or Lipitor (atorvastatin) ≥ 40 mg.
Initial Authorization: Six (6) months
Continuation of therapy with inclisiran (Leqvio) may be considered medically necessary when ALL of the following are met:
- The individual must currently be receiving a maximally tolerated statin (HMG-CoA reductase inhibitor) agent, as evidenced by paid claims or pharmacy printouts; and
- The individual must have experienced and maintained clinical benefit since starting treatment with the requested medication, as evidenced by medical documentation (e.g., chart notes) attached to the request (subject to clinical review).
Continuation Authorization: 12 months
Inclisiran (Leqvio) for any other indication not listed within this policy will be considered experimental/investigational and, therefore, not-covered. Scientific evidence does not support its efficacy or safety for any other indications.